Senior Quality Systems Software Architect

Job Summary

The Senior Quality Systems Architect is a highly experienced individual contributor responsible for the design, development, implementation, and ongoing support of GxP-regulated Quality applications within a biopharmaceutical environment.

The role operates with a high degree of autonomy, influences technical direction, and serves as a subject matter expert for software engineering best practices.

Job Responsibilities

• Design, develop, configure, and support enterprise Quality applications (e.g., eQMS, deviation/CAPA, change management, audits, document management).
• Practice software engineering standards, best practices, and architectural patterns for Quality systems.
• Provide technical guidance and mentoring to junior engineers and cross-functional team members.
• Evaluate and recommend new approaches to improve Quality system performance and compliance.
• Ensure all systems and changes comply with GxP, FDA, EMA, ICH, and other global regulatory requirements.
• Ensure data integrity, system security, and audit readiness across Quality applications.
• Translate business and quality process requirements into scalable technical solutions.
• Provide advanced troubleshooting and root cause analysis for system issues impacting Quality operations.
• Lead continuous improvement initiatives to reduce manual processes, improve system reliability, and enhance user experience.
• Lead to disaster recovery planning and exercise execution, business continuity, and system lifecycle management planning.

Required Knowledge, Skills, & Abilities

• Bachelor’s degree in Computer Science, Software Engineering, Information Systems, or related field (Master’s degree preferred).
• 8–12+ years of professional software engineering or application support experience.
• 5+ years supporting GxP-regulated systems within the pharmaceutical, biotech, or medical device industry.
• Proven experience with Quality applications (commercial or custom-built eQMS platforms).
• Demonstrated experience executing complex technical initiatives without direct people management responsibility.
• Experience with enterprise application development and/or configuration (e.g., python, APIs, SQL, databases).
• Strong understanding of Software Development Lifecycle (SDLC), Agile/DevOps practices in a regulated environment.
• Experience in Computer System Validation (CSV) methodologies, data integrity principles, and audit readiness.

Desired Knowledge, Skills, & Abilities

• Experience with EtQ
• Experience with Computer Software Assurance (CSA)
• Familiarity with FDA 21 CFR Part 11, Annex 11, and global regulatory expectations.